ISO 9001 : 2015 standards as applied to a quality management system

Abstract

ISO 9001 is an international standard of Quality Management systems (QMS). This standard describes the requirements for organisations to help them promote continual improvement and achieve customer satisfaction. The setting of the study was in Malta Medicines Authority (MMA) where the 2025 strategy includes enhancing the quality management system. This study uses qualitative methodology to evaluate the implementation of ISO 9001:2015 requirements within the quality management system. The objectives were (1) to identify gaps between existing QMS and the requirements of ISO 9001:2015 (2) to enumerate strengths and weaknesses of the QMS (3) and to formulate action plans to bridge the gap to enhance the QMS of the authority. The study involved the MMA’s Team members of the Quality, Continuous Improvement, and Internal Audit Unit. Qualitative data were gathered through Literature Review to identify the gaps between the existing QMS and the requirement of ISO 9001:2015. Critical Analysis and a focus group discussion explored the ideas regarding optimisation of the quality management system. In a literature review from 2015 until 2022, the main gaps include resistance to change, lack of resources, lack of understanding, lack of people involvement, and lack of awareness. A risk management plan addresses gaps immediately within the authority. The focus group discussion with the members of the quality unit highlighted that the authority's main objective was to be the centre of excellence and to be consistently within a high standard. Principles of Quality Management is adopted accordingly as Standard Operating Procedure was implemented within each directorate to guide each employee; Updated Quality Improvement Forms; induction and refresher training with the employees; and internal/external audits were carried out incessantly. Lastly, the authority's participation with the external auditors and quality managers to adapt its best practices improved the QMS of the authority.